510(K) Approval Requirements for Medical Device Software

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Apr 26, 2018
60 minutes
Product Description

Get to Market Faster: Don’t Risk 510(K) Denial & Delay

You know you must submit your medical device software for U.S. Food and Drug Administration (FDA) approval. But the last thing you want is to find out, after seven or more months of waiting, that your 510(K) submittal has been denied. A common reason for 510(K) denial is that the software portion of the submittal is inadequate and noncompliant.

Don’t run this approval-delay risk when you don’t have to. Learn from medical device and software development expert Nancy Knettell how to properly prepare your 510(K) documentation—specifically for the software portion of the submittal.

What’s more, Knettell will show you how to reduce your post-submittal audit risk. Serious findings uncovered after submittal can block your ability to ultimately sell your product. Knettell will arm you with the know-how you need to properly address your regulatory obligations for the 510(K) submittal preparation process.

If your medical device company is interested in submitting software-enabled devices—or software as a medical device—to the FDA for 510(K) approval, this training webinar is a must-attend event.

Session Highlights

After attending this informative session, you will understand:

  • Key guidance that the FDA expects you to follow during the Software Development and Verification/Validation Process
  • What documentation is required to support different Classes of Software for the 510(K)
  • How to set up Design Development Documentation correctly to support Verification and Validation
  • How to ensure that the software part of the 510(K) submittal is complete
  • Key compliance requirements to prevent audit risks and serious findings post submittal

Who Should Attend

  • Quality managers
  • Quality engineers
  • Regulatory affairs personnel
  • Small business owners
  • GxP
  • Consultants
  • Quality vice-presidents
  • IT vice-presidents
  • Lab directors
  • Scientists
  • FDA investigators
  • Regulatory agency investigators

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

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About Our Speaker

Nancy Knettell

Nancy Knettell is founder and principle of Signet Medical Systems, LLC. She has more than 30 years in combined Regulatory, Software Development, and Software Quality experience, primarily in the medical device industry. Knettell has also consulted with major medical companies, including Johnson & Johnson, Smith and Nephew, Philips Medical, CR Bard, and Hologic. For Knettell, involvement in the medical device industry is a personal issue. Having lost her...   More Info
More Events By The Speaker

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